Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K042595 |
Device Name |
SPIRO'AIR |
Applicant |
MORGAN SCIENTIFIC, INC. |
151 ESSEX ST. |
HAVERHILL,
MA
01832
|
|
Applicant Contact |
PATRICK MORGAN |
Correspondent |
MORGAN SCIENTIFIC, INC. |
151 ESSEX ST. |
HAVERHILL,
MA
01832
|
|
Correspondent Contact |
PATRICK MORGAN |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 09/23/2004 |
Decision Date | 05/04/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|